CN102802521A - Strip for measuring biodata and method for measuring biodata - Google Patents
Strip for measuring biodata and method for measuring biodata Download PDFInfo
- Publication number
- CN102802521A CN102802521A CN2010800325107A CN201080032510A CN102802521A CN 102802521 A CN102802521 A CN 102802521A CN 2010800325107 A CN2010800325107 A CN 2010800325107A CN 201080032510 A CN201080032510 A CN 201080032510A CN 102802521 A CN102802521 A CN 102802521A
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- CN
- China
- Prior art keywords
- blood
- ldl
- layer
- test strip
- blood sample
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/14—Devices for taking samples of blood ; Measuring characteristics of blood in vivo, e.g. gas concentration within the blood, pH-value of blood
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/52—Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements
- G01N33/525—Multi-layer analytical elements
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
- C12Q1/60—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving cholesterol
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/92—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving lipids, e.g. cholesterol, lipoproteins, or their receptors
Abstract
The present invention relates to a measurement strip used in measuring biodata. The strip comprises: an upper cover having at least one blood injection portion; a lower support having at least one area to be read; a blood-filtering layer which performs at least one of red blood cell separation and low density lipoprotein (LDL) cholesterol separation from the injected blood; a reaction layer which performs a chemical reaction with the blood from which at least one of the red blood cells and LDL cholesterol is removed; and a hydrophilizing layer interposed between the blood-filtering layer and the reaction layer to enable the blood filtered by the blood-filtering layer to be uniformly spread, wherein the blood-filtering layer, the hydrophilizing layer, and the reaction layer are vertically arranged between the lower support and the upper cover.; The thus-configured strip of the present invention protects the reaction layer from an infiltration of red blood cells, and enables blood to be easily spread, thereby reducing errors in measurement values and improving reproducibility.
Description
Invention field
The present invention relates to the measurement of biomedical data.More specifically, the present invention relates to be used to measure the test strip of the biomedical data of blood.
Description of Related Art
Total cholesterol level in known blood, blood plasma or the serum is one type of biomedical data of indication coronary sclerosis risk.But, because nearest clinical research shows between the risk of low density lipoprotein, LDL (LDL) cholesterol levels and coronary sclerosis positive correlation is arranged, thereby the LDL cholesterol levels is the medical science indicant that is superior to total cholesterol level.
Can use the test strip measurement LDL cholesterol levels that comprises suitable reactions reagent.Most of bar of measuring has such structure, and a plurality of bed courses that wherein comprise reagent in it are stacked between top covering and the below holder.Design this stepped construction so that samples vertical flows, and this structure comprises blood filtration layer and colour developing film.The shortcoming of this conventional structure is that the smoothness of the contact surface between the levels has very large deviation.In this case, the blood that arrives pad is different in interborough spreadability, thereby causes measurement error.Therefore, even the conventionally test bar can not guarantee the repeatability of biomedical data when using same sample.
Summary of the invention
Therefore, the present invention makes under the situation of having considered the problems referred to above that exist in the prior art, and an object of the present invention is to provide the test strip that can measure biomedical data credibly.
In order to reach this purpose, the invention provides a kind of and the test strip that is used to the measure biomedical data measuring device coupling, said test strip comprises: have the top covering that one or more applies the hole; Below holder with one or more test section, said test section with the corresponding position of the detecting unit of said measuring device; Blood filtration layer, this layer are designed to from the blood sample that applies, filter out erythrocyte and/or low density lipoprotein, LDL (LDL) cholesterol; Conversion zone does not wherein have the blood sample and the reagent reacting of erythrocyte and/or low density lipoprotein, LDL (LDL) cholesterol; And insert the hydrophilic layer between blood filtration layer and the conversion zone, and it is used to make through the filtering blood sample uniform spreading of filter course, and blood filtration layer and conversion zone are layered between below holder and the top covering.
Beneficial effect
Owing to have a structure of having introduced water wetted material, test strip of the present invention prevents spreadability that erythrocyte infiltrates conversion zone and improve blood reducing measurement error, thereby brings higher repeatability.
Description of drawings
Combine accompanying drawing through following detailed description, will more be expressly understood above-mentioned and other purposes, characteristic and other advantages of the present invention, in the accompanying drawings:
Fig. 1 shows to be used to the measuring device of biomedical data and to be designed to the sketch map with the test strip of its coupling;
Fig. 2 is the decomposition diagram that shows the test strip of one embodiment of the invention;
Fig. 3 shows reflectance (k/s) figure that obtains with the conventionally test bar; And.
Fig. 4 shows reflectance (k/s) figure that obtains with test strip of the present invention under the same conditions.
Preferred embodiment is described
Below will be with reference to accompanying drawing, the identical Reference numeral that uses in wherein whole different accompanying drawings is represented same or analogous parts.
Schematically illustrated device and the test strip that is used to measure biomedical data according to one embodiment of the invention of Fig. 1.Shown in the sketch map of Fig. 1, test strip 300 comprises a plurality of reaction zone 331-1,331-2 and 331-3, wherein can measure biomedical data, like blood triglyceride and cholesterol levels.Different according to its position, the tested object of reaction zone 330 can be different.The device 100 that is used to measure biomedical data comprises power knob, integral type strip adapter 130 and display 180.Strip adapter 130 has a plurality of isolated detecting units on the heart line therein.Detecting unit 110 is designed to corresponding with reaction zone 331-1,331-2 and the 331-3 of test strip 300 respectively.According to test-types, opening section or all reaction of detecting unit 110 to take place among detection reaction district 331-1,331-2 and the 331-3.In addition, reaction zone can be included in analyte and the reagent that uses in the biochemical reaction of measuring biomedical data or the chemical reaction.The test-types of biomedical data is confirmed according to the chemical reaction zone that exists in the test section of test strip or the measurement section.Therefore, may not need other evaluation sign indicating number (like bar code) to confirm test-types.
With reference to Fig. 2, show the decomposition diagram of the test strip 200 of one embodiment of the invention.Shown in this exploded perspective of Fig. 2, test strip 200 comprises having a plurality of top covering 210 in hole 211, the intermediate structure that is separable into a plurality of layer laminate and the below holders 220 of applying that are configured in wherein.
Top covering 210 has one or more and applies hole 211, can blood sample be loaded on the test strip through said hole 211 user that apply, and the measuring object in said hole can differ from one another.For example, top covering 210 has three and applies the low-density lipoprotein cholesterol level that blood is measured in hole 211.
Below in the holder 220, test section 221 is arranged in the detecting unit 110 corresponding positions with the strip adapter 130 of device 100.Device 100 is measured biomedical data through test section 221.Open test section 221 and measure the reaction result in the conversion zone 260.Can open all according to the test-types of biomedical data, any two or test section 221 only.Can measure the reaction result in the conversion zone 260 through the test section of opening 221.
Intermediate structure comprises that blood sprawls layer 230, blood filtration layer, water wetted material 250 and conversion zone 260.The blood filtration layer is partitioned erythrocyte and low density lipoprotein, LDL (LDL) cholesterol filtering area 240 and erythrocyte filtering area 245.Erythrocyte and low density lipoprotein, LDL (LDL) cholesterol filtering area is positioned at target and is that second of HDL-C (HDL) applies under the hole, and other zones are erythrocyte filtering area 245.
The main effect that the blood that constitutes by the porous polyester net, such as the Woven fabric of bafta or gauze is sprawled district 230 is to sprawl blood above that fast and equably.
Erythrocyte and low density lipoprotein, LDL (LDL) cholesterol filtering area 240 is made up of fiberglass packing, and said fiberglass packing comprises hemagglutinin (hemagglutinating agent) and LDL cholesterol precipitant.The diameter range of fiberglass packing is 0.5 to 2 micron, and length is 0.25-0.40mm, preferred 0.37mm.Hemagglutinin and precipitant all are evenly distributed on the said pad with dipping or fixed form.Being used for hemagglutinin of the present invention can be lectin, cationic polymer and/or saccharide.The instance of lectin comprises PHA (phytohaemagglutinin), concanavalin A, PWM (pokeweed mitogen) and wheat germ agglutinin.One of cationic polymer is for gathering (diallyldimethylammonium chloride).Being used for saccharide of the present invention can be monosaccharide, disaccharide and/or polysaccharide, like Sorbitol, sugar, oligosaccharide etc.Be used for the function that precipitant of the present invention plays the LDL cholesterol selective precipitation that makes blood, can be selected from sulfonated polysaccharide, heparin, phosphotungstic acid (PTA), the cationic salt of dextran sulfate and II family thereof.
Term used herein " hydrophilic layer 250 " thereby be intended to is illustrated in the material that its end group or functional group place have oxygen atom or hydroxyl to allow hydrophilic to handle, like polyvinylpyrrolidone (PVP), polyvinyl alcohol (PVA) or Polyethylene Glycol (PEG).Hydrophilic layer 250 between blood filtration layer and conversion zone 260 plays the effect of being infiltrated conversion zone 260 and sprawling filtering blood by the filtering erythrocyte of blood filtration layer of preventing not.
In a preferred embodiment of the invention, hydrophilic layer 250 can be the form of hydrophiling porous net.The aperture of this net can be 1 to 500 μ m, and thickness can be 1 μ m or littler, and can be made up of polyester.The porous net can through with hydrophilic compounds (like polyvinylpyrrolidone (PVP), polyvinyl alcohol (PVA) or Polyethylene Glycol (PEG)) reaction or through in its end group or functional group, introducing oxygen atom or hydroxyl by hydrophiling.
In a preferred embodiment of the invention, hydrophilic layer 250 can be applied to the form of gel, powder or film on conversion zone 260 or the blood filtration layer.When applying hydrophilic layer 250 with gel form, can use hydrophilic layer 250 physical package by one in conversion zone 260 and the blood filtration layer or both, perhaps can hydrophilic layer 250 be printed onto on the pad.For applying of powder type, the microgranule of hydrophilic layer is sprayed onto on conversion zone 260 or the blood filtration layer can evenly absorbs the rough surface that is filtered blood effectively to form.Under the situation of form membrane, between film (like the porous net) the insertion reaction layer and blood filtration layer that will process by water wetted material.
In order to obtain biomedical data, the blood that conversion zone 260 has been designed to and has removed erythrocyte and LDL cholesterol reacts.Conversion zone comprises can and not have the reagent that the blood of LDL cholesterol reacts with no erythrocyte.Reagent can be dipped into or be fixed in the pad.In a preferred embodiment of the invention, quantitative analysis high density lipoprotein (HDL) cholesterol.In this case; Through cholesteryl esterase the HDL cholesterol is split into free cholesterol and fatty acid; Free cholesterol and oxygen reaction forming hydrogen peroxide in the presence of COD 3-Hydroxysteroid oxidase, said hydrogen peroxide are under peroxidase and coloring agent generation color reaction.
Fig. 3 and 4 uses the conventionally test bar and under the same conditions according to reflectance map that test strip of the present invention obtained.
In Fig. 3 and 4, identical blood is written into strip, will do Fig. 5 time with respect to the reflectance (k/s) of time.Compare with Fig. 3, in the curve model of Fig. 4, observe stable converging.Some place at 90 seconds, the conventionally test bar shows 29.7 average response value, the coefficient of variation is 4.3%, and test strip of the present invention shows 27.2 average response value, the coefficient of variation is 2.6%.For the lower higher repeatability of coefficient of variation explanation of same sample.Therefore, to compare repeatability better for test strip of the present invention and conventionally test bar.
Although not in above explanation, it will be understood by those skilled in the art that to derive improved biomedical data measuring method from the present invention, thereby wherein allows hydrophilic to handle the spreadability that improves blood.Said method can comprise: blood sample is written into one or more blood applies the hole; From the blood sample that is written into, filter out one in erythrocyte and low density lipoprotein, LDL (LDL) cholesterol or both; With the hydrophilic layer uniform spreading through the filtering blood sample of filter course; And make the blood sample that passes hydrophilic layer carry out chemical reaction to obtain biomedical data.
At biomedical data to be measured is under the situation of HDL-C (HDL), can from be written into the blood sample that blood applies the hole, filter out simultaneously erythrocyte and low density lipoprotein, LDL (LDL) both.
Although disclose the preferred embodiments of the invention for illustrative purposes, it will be understood by those skilled in the art that under the prerequisite that does not deviate from disclosed scope of the present invention of accompanying claims and spirit, can carry out multiple modification, interpolation and replacement.
Claims (11)
1. test strip that is used to measure biomedical data with the measuring device coupling comprises:
Has the top covering that one or more applies the hole;
Below holder with one or more test section, said test section with the corresponding position of the detecting unit of said measuring device;
Blood filtration layer, said blood filtration layer are designed to from the blood sample that applies, filter out one in erythrocyte and low density lipoprotein, LDL (LDL) cholesterol or both;
Conversion zone does not wherein have the said blood sample and the reagent reacting of erythrocyte and/or low density lipoprotein, LDL (LDL) cholesterol; And
Insert the hydrophilic layer between said blood filtration layer and the said conversion zone, it is used to make through the filtering said blood sample uniform spreading of said filter course, and said blood filtration layer and said conversion zone are layered between said below holder and the said top covering.
2. the test strip of claim 1, wherein said hydrophilic layer has the porous net of hydrophiling.
3. the test strip of claim 2, the pore diameter range of wherein said porous net is 1 to 500 μ m.
4. the test strip of claim 1, wherein said hydrophilic layer are applied on one in said conversion zone and the said blood filtration layer or both.
5. the test strip of claim 4, wherein said hydrophilic layer applies with the form of gel, powder or film.
6. the test strip of claim 1, wherein said hydrophilic layer is selected from polyvinylpyrrolidone (PVP), polyvinyl alcohol (PVA) and Polyethylene Glycol (PEG).
7. the test strip of claim 1, wherein said hydrophilic layer is the porous net, said porous Netcom crosses and in its end group or functional group, introduces oxygen atom or hydroxyl and by hydrophiling.
8. the test strip of claim 1, wherein said test section is an open area.
9. the test strip of claim 1, said biomedical data wherein to be measured is HDL-C (HDL), and said blood filtration layer filters out erythrocyte and low density lipoprotein, LDL (LDL) cholesterol simultaneously from the blood sample that is applied.
10. method that is used to measure biomedical data may further comprise the steps:
A) blood sample is written into one or more blood and applies the hole;
B) from loaded blood sample, filter out one in erythrocyte and low density lipoprotein, LDL (LDL) cholesterol or both;
C) with the hydrophilic layer uniform spreading through the filtering said blood sample of said filter course; And
D) make the said blood sample that passes said hydrophilic layer carry out chemical reaction, to obtain biomedical data.
11. the method for claim 10, said biomedical data wherein to be measured are HDL-C (HDL), and step c) comprises and from loaded blood sample, filters out erythrocyte and low density lipoprotein, LDL (LDL) cholesterol simultaneously.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
KR10-2009-0049647 | 2009-06-04 | ||
KR1020090049647A KR101203385B1 (en) | 2009-06-04 | 2009-06-04 | Test strip improved spreadability of plasma or serum |
PCT/KR2010/002598 WO2010140771A2 (en) | 2009-06-04 | 2010-04-26 | Strip for measuring biodata and method for measuring biodata |
Publications (2)
Publication Number | Publication Date |
---|---|
CN102802521A true CN102802521A (en) | 2012-11-28 |
CN102802521B CN102802521B (en) | 2015-09-16 |
Family
ID=43298270
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN201080032510.7A Active CN102802521B (en) | 2009-06-04 | 2010-04-26 | Measure the examination bar of biological data and measure the method for biological data |
Country Status (6)
Country | Link |
---|---|
US (1) | US8293189B2 (en) |
EP (1) | EP2438859B1 (en) |
JP (1) | JP5479586B2 (en) |
KR (1) | KR101203385B1 (en) |
CN (1) | CN102802521B (en) |
WO (1) | WO2010140771A2 (en) |
Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN103320499A (en) * | 2013-05-31 | 2013-09-25 | 南京普朗医疗设备有限公司 | Dry-type biochemical test strip for simultaneously detecting trinomial blood lipid |
CN107991477A (en) * | 2017-11-27 | 2018-05-04 | 民康医疗科技(天津)有限公司 | A kind of detection reagent of triglycerides and the Test paper of triglycerides |
CN110554203A (en) * | 2019-09-17 | 2019-12-10 | 浙江大学山东工业技术研究院 | High density lipoprotein cholesterol test paper |
CN113533313A (en) * | 2020-04-20 | 2021-10-22 | 杭州微策生物技术股份有限公司 | Photochemical POCT (point of care testing) all-in-one testing system and testing method |
CN113533312A (en) * | 2020-04-20 | 2021-10-22 | 杭州微策生物技术股份有限公司 | Photochemical POCT (point of care testing) all-in-one test card |
Families Citing this family (3)
Publication number | Priority date | Publication date | Assignee | Title |
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US20140065033A1 (en) | 2012-08-31 | 2014-03-06 | Infopia Co., Ltd. | Case for specimen analyzing kit, kit for specimen analyzing, specimen analysis apparatus and control method of specimen analysis apparatus |
KR101974645B1 (en) * | 2016-12-02 | 2019-05-02 | 에스디 바이오센서 주식회사 | A strip for simultaneously measuring total-hemoglobin and glucose-6-phosphate dehydrogenase, a preparing method thereof, and a use of the same |
JP7399514B2 (en) | 2020-02-25 | 2023-12-18 | Blue Industries株式会社 | Separation equipment, detection equipment, storage equipment and sensors |
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- 2009-06-04 KR KR1020090049647A patent/KR101203385B1/en active IP Right Grant
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- 2010-03-11 US US12/722,183 patent/US8293189B2/en active Active
- 2010-04-26 EP EP10783520.9A patent/EP2438859B1/en active Active
- 2010-04-26 JP JP2012513856A patent/JP5479586B2/en not_active Expired - Fee Related
- 2010-04-26 CN CN201080032510.7A patent/CN102802521B/en active Active
- 2010-04-26 WO PCT/KR2010/002598 patent/WO2010140771A2/en active Application Filing
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US5135716A (en) * | 1989-07-12 | 1992-08-04 | Kingston Diagnostics, L.P. | Direct measurement of HDL cholesterol via dry chemistry strips |
US5213965A (en) * | 1990-07-16 | 1993-05-25 | Cholestech Corporation | Solid-phase precipitation assay device |
CN101413941A (en) * | 2001-06-29 | 2009-04-22 | Ipg501健康保健有限公司 | Test of blood specimen |
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Cited By (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN103320499A (en) * | 2013-05-31 | 2013-09-25 | 南京普朗医疗设备有限公司 | Dry-type biochemical test strip for simultaneously detecting trinomial blood lipid |
CN107991477A (en) * | 2017-11-27 | 2018-05-04 | 民康医疗科技(天津)有限公司 | A kind of detection reagent of triglycerides and the Test paper of triglycerides |
CN110554203A (en) * | 2019-09-17 | 2019-12-10 | 浙江大学山东工业技术研究院 | High density lipoprotein cholesterol test paper |
CN110554203B (en) * | 2019-09-17 | 2022-10-21 | 浙江大学山东工业技术研究院 | High density lipoprotein cholesterol test paper |
CN113533313A (en) * | 2020-04-20 | 2021-10-22 | 杭州微策生物技术股份有限公司 | Photochemical POCT (point of care testing) all-in-one testing system and testing method |
CN113533312A (en) * | 2020-04-20 | 2021-10-22 | 杭州微策生物技术股份有限公司 | Photochemical POCT (point of care testing) all-in-one test card |
Also Published As
Publication number | Publication date |
---|---|
CN102802521B (en) | 2015-09-16 |
KR101203385B1 (en) | 2012-11-21 |
JP2012529039A (en) | 2012-11-15 |
KR20100130902A (en) | 2010-12-14 |
US8293189B2 (en) | 2012-10-23 |
WO2010140771A3 (en) | 2011-01-20 |
EP2438859A4 (en) | 2012-11-28 |
JP5479586B2 (en) | 2014-04-23 |
EP2438859A2 (en) | 2012-04-11 |
US20100311154A1 (en) | 2010-12-09 |
EP2438859B1 (en) | 2016-10-12 |
WO2010140771A2 (en) | 2010-12-09 |
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Address after: Gyeonggi Do, South Korea Patentee after: Wuchang health care Co Ltd Address before: Gyeonggi Do, South Korea Patentee before: Infopia Co., Ltd. |